Literature DB >> 15994664

Drug safety and regulation.

Patrick C Waller, Stephen J W Evans, Keith Beard.   

Abstract

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Year:  2005        PMID： 15994664      PMCID： PMC558515          DOI： 10.1136/bmj.331.7507.4

Source DB:  PubMed          Journal:  BMJ        ISSN： 0959-8138


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  9 in total

1.  A model for the future conduct of pharmacovigilance.

Authors:  Patrick C Waller; Stephen J W Evans
Journal:  Pharmacoepidemiol Drug Saf       Date:  2003 Jan-Feb       Impact factor: 2.890

2.  FDA is incapable of protecting US "against another Vioxx".

Authors:  Jeanne Lenzer
Journal:  BMJ       Date:  2004-11-27

3.  Vioxx, the implosion of Merck, and aftershocks at the FDA.

Authors:  Richard Horton
Journal:  Lancet       Date:  2004 Dec 4-10       Impact factor: 79.321

4.  Vioxx: lessons for Health Canada and the FDA.

Authors: 
Journal:  CMAJ       Date:  2005-01-04       Impact factor: 8.262

5.  Safety concerns at the FDA.

Authors: 
Journal:  Lancet       Date:  2005 Feb 26-Mar 4       Impact factor: 79.321

6.  COX-2 inhibitors--a lesson in unexpected problems.

Authors:  Jeffrey M Drazen
Journal:  N Engl J Med       Date:  2005-02-15       Impact factor: 91.245

7.  Suicide, depression, and antidepressants.

Authors:  Andrea Cipriani; Corrado Barbui; John R Geddes
Journal:  BMJ       Date:  2005-02-19

8.  The influence of big pharma.

Authors:  R E Ferner
Journal:  BMJ       Date:  2005-04-16

9.  Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients.

Authors:  Munir Pirmohamed; Sally James; Shaun Meakin; Chris Green; Andrew K Scott; Thomas J Walley; Keith Farrar; B Kevin Park; Alasdair M Breckenridge
Journal:  BMJ       Date:  2004-07-03
  9 in total
  4 in total

1.  Audit is important part of drug safety and regulation.

Authors:  Michael I Carter; Jane Murkin
Journal:  BMJ       Date:  2005-08-20

Review 2.  Pharmacovigilance during the pre-approval phases: an evolving pharmaceutical industry model in response to ICH E2E, CIOMS VI, FDA and EMEA/CHMP risk-management guidelines.

Authors:  Craig G Hartford; Kasia S Petchel; Hani Mickail; Susana Perez-Gutthann; Mary McHale; John M Grana; Paula Marquez
Journal:  Drug Saf       Date:  2006       Impact factor: 5.606

3.  Drug safety information through the internet: the experience of an Italian website.

Authors:  Giovanni Polimeni; Alessandra Russo; Maria Antonietta Catania; Andrea Aiello; Alessandro Oteri; Gianluca Trifirò; Gioacchino Calapai; Lidia Sautebin; Massimo Iacobelli; Achille P Caputi
Journal:  Drug Saf       Date:  2009       Impact factor: 5.606

4.  Influence of regulatory measures on the rate of spontaneous adverse drug reaction reporting in Italy.

Authors:  Domenico Motola; Antonio Vargiu; Roberto Leone; Anita Conforti; Ugo Moretti; Alberto Vaccheri; Giampaolo Velo; Nicola Montanaro
Journal:  Drug Saf       Date:  2008       Impact factor: 5.606
  4 in total

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